Apparatus for prevention of snoring and improved breathing

TECHNICAL FIELD OF THE INVENTION

p-0002This invention relates generally to medical and dental devices, and more particularly to an apparatus for prevention of snoring and improved breathing.

BACKGROUND

p-0003Many people experience difficulty in sleeping because of breathing problems. These problems may result in snoring, or the more serious condition of sleep apnea. One treatment for sleep breathing disorders involves the use of dental devices for extending forward the lower jaw of the patient. These devices operate to more fully open the breathing passageway, thereby allowing for easier breathing, whether that breathing be through the nose or through the mouth. Furthermore, many people suffer from degraded teeth or jaw pain arising from bruxing or the grinding of teeth during sleep. One treatment for grinding involves the use of dental devices that put pressure on a patient's front teeth to relax and unclench the patient's jaw.

p-0004These dental devices may be created in labs after a dentist sends in a patient's dental impressions. This procedure can cost the patient substantial time and money because the dentist creates a dental impression and then the lab creates the dental device after the dentist sends in the dental impression. Also, these lab-created dental devices are often designed to target particular problems. For example, a device for treating snoring may not help a patient who grinds his teeth.

p-0005People who suffer from sleep problems may seek help from a sleep laboratory. Doctors at the laboratory may perform tests on patients as they sleep. Doctors may further test the effectiveness of various dental devices on the patients as treatment options. During tests, doctors may need quick access inside a patient's mouth, and dental devices that hook or attach inside the patient's mouth may hinder the doctors' ability to gain quick access inside the mouth. This scenario may also occur during surgery when a patient is unconscious, and a dental device is inserted into the mouth to maintain the patient's airway.

SUMMARY OF THE INVENTION

p-0006In accordance with the teachings of the present invention, a dental device is provided which may reduce or eliminate disadvantages and problems associated with prior art devices.

p-0007In one embodiment, a dental device is provided comprising an arched frame and a moldable tray. The arched frame may be configured to be positioned proximate to the occlusal surface of a user's dental arch such that the arched frame extends beyond the cuspids of the user's dental arch. The arched frame may define a plurality of apertures and may comprise an adjustment mechanism. The moldable tray may be coupled to the arched frame and may engage the plurality of apertures. The moldable tray may comprise a channel configured to engage at least some of the teeth of the user's dental arch.

p-0008In a particular embodiment, a dental device is provided comprising an arched frame, a moldable tray, a second arched frame, and a second moldable tray. The arched frame may be configured to be positioned proximate to the occlusal surface of a user's maxillary arch such that the arched frame extends beyond the cuspids of the user's maxillary arch. The arched frame may define a plurality of apertures and may comprise an adjustment mechanism. The adjustment mechanism may comprise a hook and a threaded adjustor. The moldable tray may be coupled to the arched frame and may engage the plurality of apertures. The moldable tray may comprise a channel configured to engage at least some of the teeth of the user's maxillary arch. The second arched frame may be configured to be positioned proximate to the occlusal surface of a user's mandibular arch such that the second arched frame extends beyond the cuspids of the user's mandibular arch. The second arched frame may define a second plurality of apertures and may comprise a receiving mechanism coupled to the lingual portion of the lower arched body. The second moldable tray may be coupled to the second arched frame and may engage the plurality of apertures. The second moldable tray may comprise a second channel configured to engage at least some of the teeth of the user's mandibular arch. The hook may engage the receiving mechanism, and the threaded adjustor may adjust the forward position of the arched frame relative to the second arched frame.

p-0009In another embodiment, a dental device may include an arched frame configured to be positioned proximate to the occlusal surface of a user's dental arch such that the arched frame extends beyond the cuspids of the user's dental arch. The arched frame may define a plurality of apertures. The dental device may further include an adjustment mechanism coupled to the arched frame. The dental device may further include a moldable tray coupled to the arched frame. The moldable tray may engage the plurality of apertures and may comprise a channel configured to engage at least some of the teeth of the user's dental arch.

p-0010In another embodiment, a dental device may include an arched frame configured to be positioned proximate to the occlusal surface of a user's maxillary arch such that the arched frame extends beyond the cuspids of the user's maxillary arch. The arched frame may define a plurality of apertures. The dental device may further include an adjustment mechanism coupled to the arched frame. The adjustment mechanism may comprise a hook and a threaded adjustor. The dental device may further include a moldable tray coupled to the arched frame. The moldable tray may engage the plurality of apertures and may comprise a channel configured to engage at least some of the teeth of the user's maxillary arch. The dental device may further include a second arched frame configured to be positioned proximate to the occlusal surface of a user's mandibular arch such that the arched frame extends beyond the cuspids of the user's mandibular arch. The second arched frame may define a second plurality of apertures. The dental device may further include a receiving mechanism coupled to the lingual portion of the second arched frame and a second moldable tray coupled to the second arched frame. The second moldable tray may engage the second plurality of apertures and may comprise a second channel configured to engage at least some of the teeth of the user's mandibular arch. The hook may engage the receiving mechanism and the threaded adjustor may adjust the forward position of the arched frame relative to the second arched frame.

p-0011In another embodiment, a universal oral appliance is provided comprising an arched frame. The arched frame may be configured to be positioned proximate to the occlusal surface of a user's dental arch such that the arched frame extends beyond the cuspids of the user's dental arch when the universal oral appliance is inserted in the user's mouth. The arched frame may have a midline that aligns substantially with the anterior midline of the user's mouth when the universal oral appliance is inserted in the user's mouth. The arched frame may define a plurality of apertures and may comprise a universal coupler configured to removably engage a dental attachment. The universal coupler may comprise a substantially planar surface proximate to and extending across the midline of the arched frame. The universal coupler may be configured to be positioned proximate to the occlusal surface of a user's incisors when the universal oral appliance is inserted in the user's mouth. The universal coupler may further comprise a first rail coupled to a first end of the substantially planar surface and a second rail coupled to a second end of the substantially planar surface. The first rail, second rail, and substantially planar surface may define a slot.

p-0012In another embodiment, a kit for use in constructing a universal oral appliance is provided. The kit may comprise an arched frame and a plurality of dental attachments. The arched frame may be configured to be positioned proximate to the occlusal surface of a user's dental arch such that the arched frame extends beyond the cuspids of the user's dental arch when the universal oral appliance is inserted in the user's mouth. The arched frame may have a midline that aligns substantially with the anterior midline of the user's mouth when the universal oral appliance is inserted in the user's mouth. The arched frame may define a plurality of apertures and may comprise a universal coupler. The universal coupler may comprise a substantially planar surface proximate to and extending across the midline of the arched frame. The substantially planar surface may be configured to be positioned proximate to the occlusal surface of a user's incisors when the universal oral appliance is inserted in the user's mouth. The universal coupler may further comprise a first rail coupled to a first end of the substantially planar surface and a second rail coupled to a second end of the substantially planar surface. The first rail, second rail, and substantially planar surface may define a slot. The kit may further comprise a plurality of dental attachments comprising a rounded projection configured to be the point of contact between the user's upper and lower dental arches to prevent the user from clenching his jaw. The plurality of dental attachments may further comprise a hook configured to engage a receiving mechanism such that the forward position of a second arched frame may be adjusted relative to the position of the arched frame.

p-0013In another embodiment, a universal oral appliance is provided comprising an arched frame, a moldable tray, and a plurality of dental attachments. The arched frame may be configured to be positioned proximate to the occlusal surface of a user's dental arch such that the arched frame extends beyond the cuspids of the user's dental arch when the universal oral appliance is inserted in the user's mouth. The arched frame may have a midline that aligns substantially with the anterior midline of the user's mouth when the universal oral appliance is inserted in the user's mouth. The arched frame may define a plurality of apertures and may comprise a universal coupler. The universal coupler may comprise a substantially planar surface proximate to and extending across the midline of the arched frame. The substantially planar surface may be configured to be positioned proximate to the occlusal surface of a user's incisors when the universal oral appliance is inserted in the user's mouth. The universal coupler may further comprise a first rail coupled to a first end of the substantially planar surface and a second rail coupled to a second end of the substantially planar surface. The first rail, second rail, and substantially planar surface may define a slot. The moldable tray may be coupled to the arched frame and may comprise a channel configured to engage at least some of the teeth of the user's dental arch. The dental attachment may include a substantially rounded projection configured to be the point of contact between the user's upper and lower dental arches to prevent the user from clenching his jaw. The dental attachment may be an adjustable hook configured to engage the receiving mechanism such that the forward position of the arched frame is adjustable relative to the position of a second arched frame. The dental attachment may be a handle.

p-0014In another embodiment, a dental device is provided comprising an arch, a dental attachment with an anchoring element, a second arch with a second anchoring element, and a tension element. The arch may be configured to engage at least some of the teeth of a user's dental arch and may have a midline that aligns substantially with the anterior midline of the user's mouth when the arch is inserted in the user's mouth. The dental attachment may be configured to engage the arch along the midline of the arch. The dental attachment may comprise an anchoring element configured to be outside the user's mouth when the arch is inserted in the user's mouth. The second arch may be configured to engage at least some of the teeth of a user's second dental arch. The second arch may have a midline that aligns substantially with the anterior midline of the user's mouth when the second arch is inserted in the user's mouth. The second anchoring element may be coupled to the second arch along the midline of the second arch. The tension element may be configured to engage the second anchoring element. The tension element may be further configured to couple to the anchoring element outside the user's mouth when the arch is inserted in the user's mouth.

p-0015In another embodiment, a kit for constructing a dental device is provided. The kit may comprise an arch, a dental attachment with an anchoring element, a second arch with a second anchoring element, and a tension element. The arch may be configured to engage at least some of the teeth of a user's dental arch and may have a midline that aligns substantially with the anterior midline of the user's mouth when the arch is inserted in the user's mouth. The dental attachment may be configured to engage the arch along the midline of the arch. The dental attachment may comprise an anchoring element configured to be outside the user's mouth when the arch is inserted in the user's mouth. The second arch may be configured to engage at least some of the teeth of a user's second dental arch. The second arch may have a midline that aligns substantially with the anterior midline of the user's mouth when the second arch is inserted in the user's mouth. The second anchoring element may be coupled to the second arch along the midline of the second arch. The tension element may be configured to engage the second anchoring element. The tension element may be further configured to couple to the anchoring element outside the user's mouth when the second arch is inserted in the user's mouth.

p-0016In another embodiment, a dental device is provided comprising an arched frame, a moldable tray, a dental attachment with an anchoring element, a second arched frame with a second anchoring element, a second moldable tray, and a tension element. The arched frame may be configured to be positioned proximate to the occlusal surface of a user's maxillary arch such that the arched frame extends beyond the cuspids of the user's maxillary arch. The arched frame may define a plurality of apertures. The moldable tray may be coupled to the arched frame and may engage the plurality of apertures. The moldable tray may comprise a channel configured to engage at least some of the teeth of the user's maxillary arch. The dental attachment may be configured to removably engage the arch along the midline of the arch. The dental attachment may comprise an anchoring element configured to be outside the user's mouth when the arch is inserted in the user' s mouth. The second arched frame may be configured to be positioned proximate to the occlusal surface of a user's mandibular arch such that the second arched frame extends beyond the cuspids of the user's mandibular arch. The second arched frame may define a second plurality of apertures. The second moldable tray may be coupled to the second arched frame and may engage the second plurality of apertures. The second moldable tray may comprise a channel configured to engage at least some of the teeth of the user's mandibular arch. The second anchoring element may be coupled to the second arch along the midline of the second arch. The tension element may be configured to removably engage the second anchoring element. The tension element may be configured to couple to the anchoring element outside the user's mouth when the second arch is inserted in the user's mouth. The dental attachment may comprise a post and a buckle coupled to a first end of the post. A second end of the post may engage the arch. The tension element may comprise a coupler and a strap coupled to the coupler. The coupler may engage the second anchoring element. A length of the strap may be configured to engage the buckle. The buckle may be configured to substantially secure the length of the strap engaging it. By increasing the length of the strap engaging the buckle, the forward position of the arched frame relative to the second arched frame may be adjusted.

p-0017Previous dental devices may be constructed in labs independent of a dentist's office. Labs could not construct custom dental devices for particular patients without first having the patients' dental impressions. Labs may also charge patients an extra fee for constructing the dental devices. In particular embodiments, the dental device may be constructed at the dentist's office without sending dental impressions to a lab, thus saving patients time and money. Furthermore, previous dental devices may be created to treat only one disorder (such as, for example, snoring or jaw-clenching). In particular embodiments, the dental device may be customized to treat multiple dental problems. As an example, and not by way of limitation, the dental device may comprise a universal coupler configured to engage various dental attachments. Each dental attachment may be designed to treat a different disorder. Additionally, previous dental devices may limit the lower jaw's range of motion when the dental devices were inserted in the user's mouth. Previous dental devices may also limit a third party's access to the user's mouth when the dental device is in the user's mouth. In particular embodiments, the dental device may comprise a tension element engaging an anchoring element outside the user's mouth. The tension element and anchoring element may pull the user's lower jaw forward without locking the user's lower jaw in place. Furthermore, a third party may pull on the tension element to open the user's airway, or a third party may release the tension element from the anchoring element to quickly gain access to a user's mouth. Certain embodiments may provide all, some, or none of these advantages. Certain embodiments may provide one or more other advantages, one or more of which may be apparent to those skilled in the art from the figures, descriptions, and claims included herein.

BRIEF DESCRIPTION OF THE DRAWINGS

p-0018<figref idrefs="DRAWINGS">FIG. 1</figref> illustrates an example arched frame.

p-0019<figref idrefs="DRAWINGS">FIG. 2A</figref> illustrates an example arched frame comprising an adjustment mechanism.

p-0020<figref idrefs="DRAWINGS">FIG. 2B</figref> illustrates an example arched frame comprising a receiving mechanism.

p-0021<figref idrefs="DRAWINGS">FIG. 2C</figref> illustrates an example arched frame comprising a receiving mechanism.

p-0022<figref idrefs="DRAWINGS">FIG. 3A</figref> illustrates an example arched frame comprising an adjustment mechanism, and an example moldable tray.

p-0023<figref idrefs="DRAWINGS">FIG. 3B</figref> illustrates an example arched frame comprising a receiving mechanism, and an example moldable tray.

p-0024<figref idrefs="DRAWINGS">FIG. 3C</figref> illustrates an example arched frame comprising an adjustment mechanism, and an example moldable tray.

p-0025<figref idrefs="DRAWINGS">FIG. 3D</figref> illustrates an example arched frame comprising a receiving mechanism, and an example moldable tray.

p-0026<figref idrefs="DRAWINGS">FIG. 4</figref> illustrates an example dental device in a user's mouth.

p-0027<figref idrefs="DRAWINGS">FIG. 5A</figref> illustrates an example universal oral appliance comprising a universal coupler.

p-0028<figref idrefs="DRAWINGS">FIG. 5B</figref> illustrates an example universal oral appliance comprising a universal coupler.

p-0029<figref idrefs="DRAWINGS">FIG. 5C</figref> illustrates an example universal oral appliance comprising a universal coupler.

p-0030<figref idrefs="DRAWINGS">FIG. 5D</figref> illustrates an example universal oral appliance comprising a universal coupler comprising a guided channel.

p-0031<figref idrefs="DRAWINGS">FIG. 5E</figref> illustrates an example universal oral appliance comprising a universal coupler comprising a raised surface.

p-0032<figref idrefs="DRAWINGS">FIG. 6</figref> illustrates an example universal oral appliance comprising a universal coupler, and an example plurality of dental attachments.

p-0033<figref idrefs="DRAWINGS">FIG. 7</figref> illustrates an example dental device in a user's mouth.

p-0034<figref idrefs="DRAWINGS">FIG. 8</figref> illustrates an example dental device comprising a universal coupler and an example dental attachment.

p-0035<figref idrefs="DRAWINGS">FIG. 9</figref> illustrates an example dental device comprising a universal coupler and an example dental attachment.

p-0036<figref idrefs="DRAWINGS">FIG. 10</figref> illustrates an example arch comprising a dental attachment.

p-0037<figref idrefs="DRAWINGS">FIG. 11</figref> illustrates an example arch comprising a tension element.

p-0038<figref idrefs="DRAWINGS">FIG. 12</figref> illustrates an example dental device comprising a dental attachment and a tension element.

p-0039<figref idrefs="DRAWINGS">FIG. 13</figref> illustrates an example dental attachment and tension element.

p-0040<figref idrefs="DRAWINGS">FIG. 14</figref> illustrates an example dental device in a user's mouth.

p-0041<figref idrefs="DRAWINGS">FIG. 15</figref> illustrates an example process for creating a dental device.

DETAILED DESCRIPTION OF THE INVENTION

p-0042<figref idrefs="DRAWINGS">FIG. 1</figref> illustrates an example arched frame <b>100</b>. Arched frame <b>100</b> may comprise an arched body <b>105</b> that defines a plurality of apertures <b>110</b> through arched frame <b>100</b>. In particular embodiments, arched frame <b>100</b> may be configured to be positioned proximate to the occlusal surface of a user's dental arch. In some embodiments, arched frame <b>100</b> may extend beyond the cuspids of the user's dental arch when arched frame <b>100</b> is inserted in the user's mouth. In some embodiments, arched frame <b>100</b> may have a consistent thickness between 1.5 and 2 millimeters. <figref idrefs="DRAWINGS">FIG. 2A</figref> illustrates an example arched frame comprising an adjustment mechanism. As shown in <figref idrefs="DRAWINGS">FIG. 2A</figref>, an arched frame <b>100</b> is provided comprising an arched body <b>105</b> defining a plurality of apertures <b>110</b> and an adjustment mechanism <b>115</b>. In particular embodiments, arched body <b>105</b> may define a plurality of grooves, or a slot. Adjustment mechanism <b>115</b> may be coupled to arched body <b>105</b> along the midline of arched frame <b>100</b>. In certain embodiments, Adjustment mechanism <b>115</b> may comprise a hook <b>120</b> and a threaded adjustor <b>125</b>. <figref idrefs="DRAWINGS">FIGS. 2B and 2C</figref> illustrate arched frames each comprising a receiving mechanism. As shown in <figref idrefs="DRAWINGS">FIGS. 2B and 2C</figref>, an arched frame <b>100</b> is provided comprising an arched body <b>105</b> defining a plurality of apertures <b>110</b> and a receiving mechanism <b>130</b>. In particular embodiments, receiving mechanism <b>130</b> may be a bar spanning a portion of the arch of arched body <b>105</b>. In other embodiments, receiving mechanism <b>130</b> may be a surface coupled to the lingual portion of arched frame <b>100</b>. In some embodiments, the surface may be rounded.

p-0043In particular embodiments, arched frame <b>100</b> may be formed from any material suitable for dental uses, for example, a hard plastic. Arched frame <b>100</b> may be formed from methyl methacrylate or a polycarbonate resin thermoplastic such as that sold under the Registered Trademark Lexan. Such materials are known to those familiar with dental devices, and other suitable materials may be used to form arched frame <b>100</b> without departing from the intended scope of the present invention.

p-0044<figref idrefs="DRAWINGS">FIGS. 3A and 3C</figref> illustrate example arched frames each comprising an adjustment mechanism and example moldable trays. As shown in <figref idrefs="DRAWINGS">FIGS. 3A and 3C</figref>, an arched frame <b>100</b> and a moldable tray <b>135</b> are provided. Arched frame <b>100</b> may comprise an arched body <b>105</b> defining a plurality of apertures <b>110</b> and an adjustment mechanism <b>115</b>. Moldable tray <b>135</b> may be coupled to arched frame <b>100</b> and may engage the plurality of apertures <b>110</b>. In particular embodiments, moldable tray <b>135</b> may form through plurality of apertures <b>110</b> to couple to two sides of arched body <b>105</b>. In some embodiments, moldable tray <b>135</b> may form into a plurality of grooves defined by arched body <b>105</b>. In some embodiments, moldable tray <b>135</b> may be secured to arched frame <b>100</b> by forming through a slot defined by arched body <b>105</b>. Moldable tray <b>135</b> may further comprise a channel <b>140</b> that is configured to engage at least some of a user's dental arch. In particular embodiments, channel <b>140</b> may engage the incisors and cuspids of the user's dental arch. In some embodiments, channel <b>140</b> may engage the incisors, cuspids, and some of the molars of the user's dental arch. In some embodiments, channel <b>140</b> may engage the incisors, cuspids, and all the molars of the user's dental arch. In particular embodiments, channel <b>140</b> may be shaped to conform to a generic user's teeth. In other embodiments, channel <b>140</b> may be a smooth channel that covers a user's teeth. In particular embodiments, channel <b>140</b> may be further shaped to conform to a particular user's teeth.

p-0045In particular embodiments, moldable tray <b>135</b> may comprise a polycaprolactone polymer or other aliphatic polyester. One or more of the polycaprolactone polymers may have the formula:

p-0046<chemistry id="CHEM-US-00001" num="00001"><img id="EMI-C00001" he="7.96mm" wi="42.42mm" file="US08783261-20140722-C00001.TIF" alt="embedded image" img-content="chem" img-format="tif" orientation="portrait" inline="no" /><attachments><attachment idref="CHEM-US-00001" attachment-type="cdx" file="US08783261-20140722-C00001.CDX" /><attachment idref="CHEM-US-00001" attachment-type="mol" file="US08783261-20140722-C00001.MOL" /></attachments></chemistry><br /> where R is an aliphatic hydrocarbon and n may range from approximately 300 to approximately 650. The present invention contemplates polycaprolactone polymers using other suitable formulas.

p-0047Moldable tray <b>135</b> may include any suitable polycaprolactone polymer or other aliphatic polyester, for example, and not by way of limitation, the TONE P 700, TONE P 767, or TONE P 787 polycaprolactone polymers manufactured by Union Carbide Corporation, taken singly or in any combination. A suitable light cured material, another polymer, or any other suitable material, such as a filler, coloring agent, stabilizer, antioxidant, or antimicrobial agent, may be used to replace or combine with one or more of the polycaprolactone polymers in forming a deformable material <b>20</b> having any number of characteristics, properties, or uses.

p-0048The TONE polycaprolactone polymers are described in U.S. Pat. Nos. 5,112,225 and 4,784,123, and in literature distributed by Union Carbide Corporation, as homopolymers, block copolymers, graft copolymers, or other polymers that contain epsilon caprolactone. Polymerization may be initiated using one or more diols, for example, and not by way of limitation, ethylene glycol; diethylene glycol; neopentyl glycol; butane diol; hexane diol; or any other suitable diol.

p-0049In particular embodiments, moldable tray <b>135</b> may be custom molded to a user's teeth. For example, moldable tray <b>135</b> may comprise a material that is moldable when heated. Once heated, the material may be pressed around a user's dental arch to form a moldable tray <b>135</b> that conforms to the user's teeth. In particular embodiments, moldable tray <b>135</b> may be used with arched frame <b>100</b> to form a custom dental device. For example, arched frame <b>100</b> may comprise a hard plastic material. When moldable tray <b>135</b> is forming around a user's teeth, arched frame <b>100</b> may be pressed against moldable tray <b>135</b>, so that mold tray <b>135</b> forms through plurality of apertures <b>110</b> defined by arched body <b>105</b>. As moldable tray <b>135</b> cools and hardens, moldable tray <b>135</b> may couple to arched frame <b>100</b> through plurality of apertures <b>110</b>. In some embodiments, moldable tray <b>135</b> may couple to arched frame <b>100</b> through a slot or by forming into a plurality of grooves. In particular embodiments, arched frame <b>100</b> may provide structural support for moldable tray <b>135</b> as moldable tray <b>135</b> engages the user's teeth. For example, as moldable tray <b>135</b> engages the user's teeth, arched frame <b>100</b> may prevent moldable tray <b>135</b> from deforming or shifting under the stresses caused by movement of the user's mouth.

p-0050In particular embodiments, a custom dental device may comprise arched frame <b>100</b> and moldable tray <b>135</b>. A dentist may be able to construct the custom dental device for a patient without having to send the patient's dental impressions to a lab. The dentist may heat moldable tray <b>135</b> and press moldable tray <b>135</b> around the user's teeth. The dentist may then press arched frame <b>100</b> against moldable tray <b>135</b> to construct the custom dental device. As a result, the patient may not have to wait for the lab to create the dental device, nor does the patient have to pay an extra fee charged by the lab.

p-0051<figref idrefs="DRAWINGS">FIGS. 3B and 3D</figref> illustrate example arched frames each comprising a receiving mechanism, and example moldable trays. As shown in <figref idrefs="DRAWINGS">FIGS. 3B and 3D</figref>, an arched frame <b>100</b> and a moldable tray <b>135</b> are provided. Arched frame <b>100</b> may comprise an arched body <b>105</b> defining a plurality of apertures <b>110</b> and a receiving mechanism <b>130</b>. Receiving mechanism <b>130</b> may be coupled to arched body <b>105</b>. In particular embodiments, receiving mechanism <b>130</b> may be a bar that spans a portion of the arch of arched body <b>105</b>. Moldable tray <b>135</b> may comprise a channel <b>140</b> that is configured to engage at least some of the teeth of a user's dental arch.

p-0052<figref idrefs="DRAWINGS">FIG. 4</figref> illustrates an example dental device in a user's mouth. As shown in <figref idrefs="DRAWINGS">FIG. 4</figref>, a dental device is provided that comprises an arched frame <b>100</b>, a moldable tray <b>135</b>, a second arched frame <b>200</b>, and a second moldable tray <b>235</b>. Arched frame <b>100</b> may comprise an adjustment mechanism <b>115</b> that comprises a hook <b>120</b> and a threaded adjustor <b>125</b>. Moldable tray <b>135</b> may be coupled to arched frame <b>100</b>. Moldable tray <b>100</b> may comprise a channel <b>140</b>. In some embodiments, channel <b>140</b> may be shaped to conform to a generic user's maxillary arch <b>305</b>. In other embodiments, channel <b>140</b> may be a smooth channel that covers some of teeth of a user's maxillary arch <b>305</b>. In particular embodiments, channel <b>140</b> may be further shaped to conform to a particular user's maxillary arch <b>305</b>. Second arched frame <b>200</b> may comprise a second arched body <b>205</b> defining a second plurality of apertures <b>210</b>. Second arched frame <b>200</b> may further comprise a receiving mechanism <b>130</b> coupled to the lingual portion of second arched body <b>205</b>. In some embodiments, receiving mechanism <b>130</b> may be a bar that spans a portion of the arch of second arched body <b>205</b>. Second moldable tray <b>235</b> may be coupled to second arched frame <b>200</b> and may engage second plurality of apertures <b>210</b>. Second moldable tray <b>235</b> may be configured to engage some of the teeth of the user's mandibular arch <b>300</b>. In particular embodiments, hook <b>120</b> may engage receiving mechanism <b>130</b>. Threaded adjustor <b>125</b> may be used to adjust the forward position of arched frame <b>100</b> relative to second arched frame <b>200</b>. The relative positions of the two arched frames <b>100</b> and <b>200</b> may adjust the position of the user's maxillary arch <b>305</b> relative to the user's mandibular arch <b>300</b>. In some embodiments, the relative position of the user's maxillary and mandibular arches may help to improve a user's breathing and/or prevent the user from snoring while sleeping.

p-0053<figref idrefs="DRAWINGS">FIGS. 5A and 5B</figref> each illustrate an example universal oral appliance comprising a universal coupler. As shown in <figref idrefs="DRAWINGS">FIGS. 5A and 5B</figref>, a universal oral appliance is provided comprising an arched frame <b>100</b> and a moldable tray <b>135</b> coupled to arched frame <b>100</b>. Arched frame <b>100</b> may comprise an arched body <b>105</b> defining a plurality of apertures <b>110</b>. In particular embodiments, arched frame <b>100</b> may be configured to be positioned proximate to the occlusal surface of a user's dental arch such that arched frame <b>100</b> extends beyond the cuspids of the user's dental arch when arched frame <b>100</b> is inserted in the user's mouth. Arched frame <b>100</b> may have a midline that aligns substantially with the anterior midline of the user's mouth when arched frame <b>100</b> is inserted in the user's mouth. Arched frame <b>100</b> may further comprise a universal coupler. In particular embodiments, the universal coupler may comprise a substantially planar surface <b>145</b>, a first rail <b>146</b>, and a second rail <b>147</b>. Substantially planar surface <b>145</b> may be proximate to and extend across the midline of arched frame <b>100</b>. In particular embodiments, substantially planar surface <b>145</b> may be configured to be positioned proximate to the occlusal surface of a user's incisors when the universal oral appliance is inserted in the user's mouth. First rail <b>146</b> may be coupled to a first end of substantially planar surface <b>145</b>. In particular embodiments, first rail <b>146</b> may be distal to the midline of arched frame <b>100</b>. In other embodiments, first rail <b>146</b> may be anterior to arched frame <b>100</b>. Second rail <b>147</b> may be coupled to a second end of substantially planar surface <b>145</b>. In particular embodiments, second rail <b>147</b> may be distal to the midline of arched frame <b>100</b>. In other embodiments, second rail <b>147</b> may be posterior to arched frame <b>100</b>. First rail <b>146</b> and second rail <b>147</b> may form an acute angle with substantially planar surface <b>145</b>. In particular embodiments, first rail <b>146</b>, second rail <b>147</b>, and substantially planar surface <b>145</b> may define a slot. In particular embodiments, a dental attachment may slide into the slot and engage arched frame <b>100</b>. In some embodiments, the universal coupler may comprise a locking mechanism (such as, for example, a screw, a tab, or a groove). The screw may secure a dental attachment to the universal coupler by screwing through the dental attachment and into the universal coupler. The tab may secure the dental attachment by engaging the exterior of the dental attachment or by engaging a slot in the dental attachment. The groove may secure the dental attachment by frictionally engaging the dental attachment. In particular embodiments, the universal coupler may further comprise a stop <b>148</b> coupled to substantially planar surface <b>145</b>. Stop <b>148</b> may be coupled to the labial or lingual ends of substantially planar surface <b>145</b>. Alternatively, stop <b>148</b> may be coupled to a distal end of substantially planar surface <b>145</b>. Although this disclosure describes a universal oral appliance comprising arched frame <b>100</b>, moldable tray <b>135</b>, and a universal coupler coupled to arched frame <b>100</b>, this disclosure contemplates a one-piece universal oral appliance and a universal coupler coupled to the universal oral appliance.

p-0054<figref idrefs="DRAWINGS">FIG. 5C</figref> illustrates an example universal oral appliance comprising a universal coupler. As shown in <figref idrefs="DRAWINGS">FIG. 5C</figref>, a universal oral appliance is provided comprising an arched frame <b>100</b> and a moldable tray <b>135</b> coupled to arched frame <b>100</b>. Arched frame <b>100</b> may comprise a universal coupler comprising a substantially planar surface <b>145</b>, a first rail <b>146</b>, a second rail <b>147</b>, and a stop <b>148</b>. In particular embodiments, each rail <b>146</b> and <b>147</b> may comprise a first segment <b>149</b> and a second segment <b>150</b>. First segment <b>149</b> may be coupled at a first end to substantially planar surface <b>145</b>, and second segment <b>150</b> may be coupled to a second end of first segment <b>149</b>. In particular embodiments, first segment <b>149</b> and second segment <b>150</b> may be substantially perpendicular to each other.

p-0055<figref idrefs="DRAWINGS">FIG. 5D</figref> illustrates an example universal oral appliance comprising a universal coupler comprising a guided channel. As shown in <figref idrefs="DRAWINGS">FIG. 5D</figref>, a universal oral appliance is provided comprising an arched frame <b>100</b> and a moldable tray <b>135</b>. Arched frame <b>100</b> may comprise a universal coupler comprising a substantially planar surface <b>145</b>, a first rail <b>146</b>, a second rail <b>147</b>, and a stop <b>148</b>. First rail <b>146</b>, second rail <b>147</b>, and substantially planar surface <b>145</b> may define a slot. In particular embodiments, the universal coupler may further comprise a guided channel <b>151</b>. Guided channel <b>151</b> may be configured to guide a dental attachment through the slot.

p-0056<figref idrefs="DRAWINGS">FIG. 5E</figref> illustrates an example universal oral appliance comprising a universal coupler comprising a raised surface <b>152</b>. As shown in <figref idrefs="DRAWINGS">FIG. 5E</figref>, a universal oral appliance is provided comprising an arched frame <b>100</b> and a moldable tray <b>135</b>. Arched frame <b>100</b> may comprise a universal coupler comprising a substantially planar surface <b>145</b>, a first rail <b>146</b>, a second rail <b>147</b>, and a stop <b>148</b>. First rail <b>146</b>, second rail <b>147</b>, and substantially planar surface <b>145</b> may define a slot. In particular embodiments, the universal coupler may further comprise a raised surface <b>152</b>. Raised surface <b>152</b> may be configured to guide a dental attachment through the slot. In particular embodiments, raised surface <b>152</b> may be further configured to secure or lock the dental attachment.

p-0057<figref idrefs="DRAWINGS">FIG. 6</figref> illustrates an example universal oral appliance comprising a universal coupler, and an example plurality of dental attachments <b>400</b>. As shown in <figref idrefs="DRAWINGS">FIG. 6</figref>, an example universal oral appliance is provided that comprises an arched frame <b>100</b> and a moldable tray <b>135</b>. Arched frame <b>100</b> comprises an arched body <b>105</b> that defines a plurality of apertures <b>110</b>. Arched frame <b>100</b> further comprises a universal coupler. The universal coupler may comprise a substantially planar surface <b>145</b>, a first rail <b>146</b>, a second rail <b>147</b>, and a stop <b>148</b>. In particular embodiments, first rail <b>146</b>, second rail <b>147</b>, and substantially planar surface <b>145</b> may define a slot. <figref idrefs="DRAWINGS">FIG. 6</figref> also illustrates a plurality of dental attachments <b>400</b>. In particular embodiments, the plurality of dental attachments <b>400</b> may comprise dental attachments configured to treat different disorders. For example, the plurality of dental attachments <b>400</b> may include a hook <b>405</b>, a substantially rounded projection <b>415</b>, and an adjustable hook <b>420</b>. Other attachments may include a handle or any other appropriate attachment configured for use with an oral appliance. A user or a medical professional may choose which dental attachment to use without having to hire a lab to construct a new oral appliance. In some embodiments, dental attachments <b>400</b> may be configured to engage the slot.

p-0058<figref idrefs="DRAWINGS">FIG. 7</figref> illustrates an example dental device in a user's mouth. As shown in <figref idrefs="DRAWINGS">FIG. 7</figref>, a dental device is provided that comprises an arched frame <b>100</b>, a moldable tray <b>135</b> coupled to arched frame <b>100</b>, a second arched frame <b>200</b>, and a second moldable tray <b>235</b> coupled to arched frame <b>200</b>. Arched frame <b>100</b> may comprise a universal coupler. The universal coupler may comprise a stop <b>148</b>. Moldable tray <b>135</b> may comprise a channel <b>140</b> that is configured to engage at least some of the teeth of the user's maxillary arch <b>305</b>. Second arched frame <b>200</b> may comprise a second arched body <b>205</b> that defines a second plurality of apertures <b>210</b>. Second arched frame <b>200</b> may further comprise a receiving mechanism <b>130</b> that spans the lingual portion of second arched frame <b>200</b>. In particular embodiments, receiving mechanism <b>130</b> may be a bar. Second moldable tray <b>235</b> may engage second plurality of apertures <b>210</b>. The dental device further comprises a dental attachment that is configured to engage the universal coupler. In some embodiments, the dental attachment may be an adjustable hook <b>420</b> that comprises a hook <b>120</b> and a threaded adjustor <b>125</b>. Hook <b>120</b> may engage receiving mechanism <b>130</b>. Threaded adjustor <b>125</b> may be used to adjust the forward position of second arched frame <b>200</b> relative to arched frame <b>100</b>. This adjustment may adjust the forward position of the user's mandibular arch <b>300</b> relative to the position of the user's maxillary arch <b>305</b>. In some embodiments, this adjustment may help to prevent the user from snoring while sleeping.

p-0059<figref idrefs="DRAWINGS">FIG. 8</figref> illustrates an example dental device comprising a universal coupler and an example dental attachment. As shown in <figref idrefs="DRAWINGS">FIG. 8</figref>, a dental device is provided comprising an arched frame <b>100</b>, a moldable tray <b>135</b>, a second arched frame <b>200</b>, and a second moldable tray <b>235</b>. Arched frame <b>100</b> may comprise a universal coupler comprising a substantially planar surface <b>145</b>. In particular embodiments, a hook <b>405</b> may be configured to engage the universal coupler. In particular embodiments, second arched frame <b>200</b> may comprise a receiving mechanism <b>130</b> coupled to the lingual portion of second arched frame <b>200</b>. Receiving mechanism <b>130</b> may be a bar that spans the lingual portion of second arched frame <b>200</b>. In particular embodiments, hook <b>405</b> may engage receiving mechanism <b>130</b> to adjust the forward position of arched frame <b>100</b> relative to second arched frame <b>200</b>. In certain embodiments, this adjustment may help to prevent a user from snoring when the dental device is inserted in the user's mouth.

p-0060<figref idrefs="DRAWINGS">FIG. 9</figref> illustrates an example dental device comprising a universal coupler and an example dental attachment. As shown in <figref idrefs="DRAWINGS">FIG. 9</figref>, a dental device is provided comprising an arched frame <b>100</b>, a moldable tray <b>135</b>, a second arched frame <b>200</b>, and a second moldable tray <b>235</b>. Arched frame <b>100</b> may comprise a universal coupler comprising a substantially planar surface <b>145</b>. In particular embodiments, a substantially rounded projection <b>415</b> may be configured to engage the universal coupler. In particular embodiments, rounded projection <b>415</b> may be the only point of contact between the user's upper and lower dental arches to prevent a user from clenching his jaw when the dental device is inserted in the user's mouth. In particular embodiments, rounded projection <b>415</b> may contact an opposing arch or may contact one or more incisors of the opposing dental arch to prevent a user from clenching his jaw when the dental device is inserted in the user's mouth. The opposing arch may have a contact surface that may be planar.

p-0061The universal oral appliance comprising a universal coupler may provide several advantages for a user. In particular embodiments, a universal oral appliance comprising a universal coupler may offer more use options to a user. For example, a user's appliance may be fitted with several different dental attachment options. The user may choose which dental attachment is best suited for his situation without having to hire a lab to construct another appliance. In particular embodiments, a particular user may also adjust the dental attachment to better suit the shape and size of the user's mouth. This disclosure contemplates the universal oral appliance being created from parts in a kit. A user may purchase the kit instead of a dental device created in a laboratory.

p-0062<figref idrefs="DRAWINGS">FIG. 10</figref> illustrates an example arch comprising a dental attachment. As shown in <figref idrefs="DRAWINGS">FIG. 10</figref>, an arch is provided that comprises an arched frame <b>100</b> and a moldable tray <b>135</b> coupled to arched frame <b>100</b>. Arched frame <b>100</b> comprises an arched body <b>105</b> that defines a plurality of apertures <b>110</b>. The arch may further comprise a dental attachment configured to engage arched frame <b>100</b>. In particular embodiments, the dental attachment is configured to engage arched frame <b>100</b> along the midline of arched frame <b>100</b>. In particular embodiments, the dental attachment may comprise a post <b>500</b> and an anchoring element <b>505</b>. Post <b>500</b> may be coupled at a first end to anchoring element <b>505</b>. In particular embodiments, a second end of post <b>500</b> may engage arched frame <b>100</b>. In some embodiments, post <b>500</b> may be configured to removably engage arched frame <b>100</b>. In particular embodiments, anchoring element <b>505</b> may include a buckle, a slot, a clasp, a clamp, and/or any other appropriate element to anchor a tension element. In some embodiments, anchoring element <b>505</b> may be configured to be outside a user's mouth when the arch is inserted in the user's mouth. In some embodiments, the dental attachment may further comprise a release mechanism <b>510</b>. As an example and not by way of limitation, release mechanism <b>510</b> may be a button or a latch. Although this disclosure describes certain types of release mechanisms <b>510</b>, this disclosure contemplates any suitable release mechanism <b>510</b>. Although this disclosure describes an arch comprising arched frame <b>100</b>, moldable tray <b>135</b>, and a dental attachment, this disclosure contemplates a one-piece arch comprising a dental attachment.

p-0063<figref idrefs="DRAWINGS">FIG. 11</figref> illustrates an example arch comprising a second anchoring element and a tension element. As shown in <figref idrefs="DRAWINGS">FIG. 11</figref>, an arch is provided that comprises an arched frame <b>200</b> and a moldable tray <b>235</b> coupled to arched frame <b>200</b>. Arched frame <b>200</b> comprises an arched body <b>205</b> that defines a plurality of apertures <b>210</b>. The arch may further comprise a second anchoring element <b>245</b>. In particular embodiments, second anchoring element <b>245</b> may be coupled to the arch along the midline of the arch. The arch may further comprise a tension element <b>515</b>. In particular embodiments, tension element <b>515</b> may be flexible and may be configured to engage second anchoring element <b>245</b>. In particular embodiments, tension element <b>515</b> may be further configured to couple to an anchoring element outside a user's mouth when the arch is inserted in the user's mouth. In some embodiments, tension element <b>515</b> may comprise a strap <b>520</b> and a coupler <b>516</b>. Coupler <b>516</b> may be configured to engage the second anchoring element. In particular embodiments, coupler <b>516</b> may be configured to removably engage the second anchoring element. Strap <b>520</b> may be coupled to coupler <b>516</b>. In particular embodiments, strap <b>520</b> may be configured to engage the anchoring element outside the user's mouth when the arch is inserted in the user's mouth. In particular embodiments, strap <b>520</b> may comprise a hard plastic, leather, or metal. In certain embodiments, strap <b>520</b> may be a zip tie. In other embodiments, strap <b>520</b> may be a wire, belt, string, or any other appropriate element to engage the anchoring element. Although this disclosure describes an arch comprising arched frame <b>200</b>, moldable tray <b>235</b>, and tension element <b>515</b>, this disclosure contemplates a one-piece arch comprising tension element <b>515</b>.

p-0064<figref idrefs="DRAWINGS">FIG. 12</figref> illustrates an example dental device comprising a dental attachment, a second anchoring element, and a tension element. As shown in <figref idrefs="DRAWINGS">FIG. 12</figref>, a dental device is provided that comprises an arched frame <b>100</b> and a second arched frame <b>200</b>. The dental device further comprises a moldable tray <b>135</b> coupled to arched frame <b>100</b> and a second moldable tray <b>235</b> coupled to second arched frame <b>200</b>. The dental device may further comprise a dental attachment configured to engage arched frame <b>100</b>. In particular embodiments, the dental attachment may comprise a post <b>500</b> and an anchoring element <b>505</b>. The dental device may further comprise a second anchoring element <b>245</b>. Second anchoring element <b>245</b> may be coupled to second arched frame <b>200</b>. The dental device may further comprise a tension element <b>515</b>. Tension element <b>515</b> may be configured to engage second anchoring element <b>245</b>. In particular embodiments, tension element <b>515</b> may comprise a coupler <b>516</b> and a strap <b>520</b>. In particular embodiments, strap <b>520</b> may be configured to engage anchoring element <b>505</b> outside the user's mouth when the dental device is inserted in the user's mouth. Anchoring element <b>505</b> may be configured to secure substantially the length of strap <b>520</b> engaged to anchoring element <b>505</b>. In particular embodiments, increasing the length of strap <b>520</b> engaged to anchoring element <b>505</b> will adjust the forward position of arched frame <b>100</b> relative to second arched frame <b>200</b>. In particular embodiments, the dental attachment may further comprise a release mechanism <b>510</b>.

p-0065<figref idrefs="DRAWINGS">FIG. 13</figref> illustrates an example dental attachment and tension element. As shown in <figref idrefs="DRAWINGS">FIG. 13</figref>, a dental attachment is provided comprising a post <b>500</b> and an anchoring element <b>505</b>. Anchoring element <b>505</b> may be coupled to an end of post <b>500</b>. A tension element is also provided comprising a strap <b>520</b>. Strap <b>520</b> may be configured to engage anchoring element <b>505</b>. Anchoring element <b>505</b> may be configured to secure the length of strap <b>520</b> engaged to anchoring element <b>505</b>. In particular embodiments, the dental attachment may comprise a release mechanism <b>510</b>. Release mechanism <b>510</b> may be configured to release strap <b>520</b> from anchoring element <b>505</b>.

p-0066<figref idrefs="DRAWINGS">FIG. 14</figref> illustrates an example dental device in a user's mouth. As shown in <figref idrefs="DRAWINGS">FIG. 14</figref>, a dental device is provided that comprises an arched frame <b>100</b>, a second arched frame <b>200</b>, a moldable tray <b>135</b> coupled to arched frame <b>100</b>, and a second moldable tray <b>235</b> coupled to second arched frame <b>200</b>. Moldable tray <b>135</b> may comprise a channel <b>140</b> configured to engage at least some of the teeth of the user's maxillary arch <b>305</b>. Second arched frame may comprise a second arched body <b>205</b> that defines a second plurality of apertures <b>210</b>. The dental device may further comprise a dental attachment. The dental attachment may comprise a post <b>500</b> and an anchoring element <b>505</b>. Anchoring element <b>505</b> may be coupled to an end of post <b>500</b>, and a second end of post <b>500</b> may be configured to engage arched frame <b>100</b>. Anchoring element <b>505</b> may be configured to be outside the user's mouth when the dental device is inserted in the user's mouth. The dental device may further comprise a second anchoring element <b>245</b> coupled to second arched frame <b>200</b>. The dental device may further comprise a tension element comprising a coupler <b>516</b> and a strap <b>520</b>. Coupler <b>516</b> may be configured to engage second anchoring element <b>245</b>. Strap <b>520</b> may be coupled to coupler <b>516</b> and may be configured to engage anchoring element <b>520</b> outside the user's mouth when the dental device is inserted in the user's mouth. Anchoring element <b>505</b> may be configured to secure substantially the length of strap <b>520</b> engaged to anchoring element <b>505</b>. In particular embodiments, increasing the length of strap <b>520</b> engaged to anchoring element <b>505</b> may adjust the forward position of arched frame <b>100</b> relative to second arched frame <b>200</b>. In particular embodiments, adjusting the forward position of arched frame <b>100</b> relative to second arched frame <b>200</b> may adjust the forward position of the user's maxillary arch <b>305</b> relative to the user's mandibular arch <b>300</b>. In particular embodiments, adjusting the forward position of the user's maxillary arch <b>305</b> relative to the position of the user's mandibular arch <b>300</b> may help to improve the user's breathing and/or prevent the user from snoring.

p-0067In particular embodiments, the dental device comprising a dental attachment and a tension element may allow a third party faster access to a user's mouth and airway. For example, if the user is a patient sleeping in a sleep laboratory, a doctor in the laboratory may quickly pull on the tension element to open an airway that closed while the patient slept. As another example, if the user is a patient undergoing surgery in a hospital, a surgeon may quickly release the tension element to open the patient's mouth for intubation or for insertion of an instrument while the patient is sedated. In particular embodiments, the dental device comprising a dental attachment and a tension element may pull the user's lower jaw forward without locking the lower jaw in place. The user's lower jaw will maintain a certain range of lateral motion while the dental device is inserted in the user's mouth. This disclosure contemplates the dental device comprising a dental attachment and a tension element being created from a kit. A patient, doctor, or surgeon may purchase the kit and create the dental device quickly. In particular embodiments, the dental device may be a disposable device that may be thrown out after one or more uses.

p-0068<figref idrefs="DRAWINGS">FIG. 15</figref> illustrates an example process for creating a dental device. At step <b>600</b>, an arched frame is formed. In particular embodiments, the arched frame may be configured to be positioned proximate to the occlusal surface of a user's dental arch such that the arched frame extends beyond the cuspids of the user's dental arch. The arched frame may define a plurality of apertures. At step <b>605</b>, an adjustment mechanism is coupled to the arched frame. In particular embodiments, the adjustment mechanism may comprise a hook and a threaded adjustor. At step <b>610</b>, a moldable tray is formed. In particular embodiments, the moldable tray may comprise a channel configured to engage at least some of the teeth of the user's dental arch. In some embodiments, the channel may be shaped to conform to the teeth of a generic user's dental arch. In other embodiments, the channel may be a smooth channel configured to cover some of the teeth of the user's dental arch. In particular embodiments, the channel may be further shaped to conform to a particular user's dental arch. At step <b>615</b>, the moldable tray is coupled to the arched frame. In particular embodiments, the moldable tray may engage the plurality of apertures. In particular embodiments the process may be repeated to form a second arched frame and a second moldable tray. In particular embodiments, the arched frame may comprise kevlar polycarbon, acrylic, polycarbonate resin thermoplastic, or any other suitable hard plastic polymer. In particular embodiments, the moldable tray may comprise polycaprolactone.

p-0069In particular embodiments, the process illustrated in <figref idrefs="DRAWINGS">FIG. 15</figref> may lead to faster creation and production of dental devices. Users may avoid sending dental impressions to a laboratory to create a dental devices thus saving time and money.

p-0070Although example steps are illustrated and described, the present invention contemplates two or more steps taking place substantially simultaneously or in a different order. For example, step <b>605</b>, coupling an adjustment mechanism to the arched frame, may be performed after step <b>610</b>, forming a moldable tray. In addition, the present invention contemplates using methods with additional steps, fewer steps, or different steps, so long as the steps remain appropriate for creating a dental device.

p-0071Although the present invention has been described above in connection with several embodiments, changes, substitutions, variations, alterations, transformations, and modifications may be suggested to one skilled in the art, and it is intended that the present invention encompass such changes, substitutions, variations, alterations, transformations, and modifications as fall within the spirit and scope of the appended claims.